Alcon industries inc

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Reddy's Labs Ltd. By seeking the stay, the generic was not cooperating in expediting the action; therefore, the month stay was also extended. Novartis argued that "it would be an abuse of the statutory scheme to allow an [ANDA] applicant … [to] benefit from a stay of litigation by letting the clock run on the thirty-month stay of FDA approval. The court agreed and held that "[w]ith an extension of the month stay, Novartis will not be disadvantaged by a stay of these proceedings.

Thus, the Novartis court addressed possible prejudice, the first factor for granting a stay — the factor that the Alcon court overlooked — and concluded that without the extension, the patentee would be prejudiced. Admittedly, the Novartis court's decision was straightforward because the terms of the statue were satisfied. The court's reasoning, however, on possible prejudice is equally valid even where both parties cooperate in expediting the action.

The Alcon court next cites Cima Labs Inc. June 7, , where the court granted Cima's request to stay the action, but denied defendants' request to extend the month regulatory stay. The court found that defendants' reliance on 21 U. Regardless, the court did not hold that the statute limited its inherent power to extend the month stay.

In Abbott Laboratories v. Matrix Laboratories Inc. The defendants had argued that without the extension, it would be prejudiced because it could lose the day market exclusivity afforded to the first-filed generic.

Abbott could suffer prejudice if any motion for a stay were not accompanied by an order tolling the month limitations period.

But for tolling, the month period could run during the pendency of the stay. However, Defendants' motion to stay the action has been accompanied by a request that the Court toll the limitations period. In conclusion, the court stated: "In sum, the Court concludes that Abbott's interests will not be harmed by issuing a stay because the court also orders the tolling of the [month] limitation period. Thus, the court specifically recognized that the first factor for granting a stay — prejudice to the nonmoving party — was eliminated only where the litigation stay was accompanied by a corresponding stay of the month period.

Like Novartis, this decision highlights the Alcon's court's failure to fully consider the first factor in granting the stay. In Eli Lilly and Co. Accord Healthcare Inc.

Lilly argued that it would be prejudiced if the action were not resolved before the month stay expired and therefore, this period should be extended. The court denied Lilly's request and ruled that the only basis to extend the month stay was a party's failure to cooperate in expediting the litigation. If the action were not completed within 30 months, Lilly could move for a preliminary injunction "which would eliminate any alleged prejudice.

Surprisingly, the court found that this statute specifically authorizing an extension did not apply, even though the defendants had requested the stay. Both the Alcon and Lilly courts held that they were powerless to stay the 30 — unless a party was not cooperating to expedite the action. Both courts, however, recognized that one relevant factor in deciding to grant a stay was the lack of prejudice to the nonmoving party. But the Novartis and Cima courts both recognized that prejudice would result if a Hatch-Waxman action were stayed without extending the month period.

If a court has inherent power to stay a litigation, it has the corresponding power to extend the month stay. Otherwise, the first factor authorizing the litigation stay — absence of prejudice — would not be satisfied.

The explicit provision allowing the modification of the month stay to 'punish' a non-cooperating party does not deprive the court of its inherent power to extend that period when it stays the related litigation. The possibility of a preliminary injunction, which the Alcon and Lilly courts submit removes any prejudice, does not solve the problem.

Clearly, the availability of an uncertain result from a preliminary injunction motion is small consolation for depriving the patentee of the certainty of the month stay. Indeed, a patentee should not be forced to pursue this remedy when the act — as shown from its legislative history — was specifically designed to avoid this very uncertainty. The considerations regarding the grant of a litigation stay dictate that an extension of 30 months is also warranted.

Indeed, the regulatory stay was extended from 18 to 30 months to "increase the likelihood" that patent disputes would be resolved before a generic product could be marketed. Both the Alcon and Lilly courts disregarded this important statutory purpose. In a given case, the patentee or the generic or possibly both may argue that a litigation stay is only appropriate if the month period is corresponding extended.

The decision will depend on the specific facts, but the court should not deny the extension, because it lacks the power to do so. The opinions expressed are those of the author s and do not necessarily reflect the views of the firm, its clients, or Portfolio Media Inc. This article is for general information purposes and is not intended to be and should not be taken as legal advice. Sandoz, Inc. This post is for general information purposes only and is not intended to be and should not be taken as legal advice.

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